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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01FD005114-01A2 | U.S. FDA Grant/Contract | View source |
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| Name | Class |
|---|---|
| Creighton University | OTHER |
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The purpose of this research study is to evaluate antiresorptive therapy with denosumab (Prolia) for prevention of bone loss after stopping teriparatide (TPTD) in premenopausal women with idiopathic osteoporosis.
Premenopausal women who have received TPTD in the FDA Orphan Diseases Program-funded trial, "A Phase 2 Study of Teriparatide for the Treatment of Idiopathic Osteoporosis in Premenopausal Women" (NCT01440803) may be eligible to participate in the current study, a 36-month open-label pilot study of denosumab (Prolia®, 60mg subcutaneous (SC) every 6 months).
The goals of the study are to estimate the effects of denosumab on central and peripheral, as well as trabecular and cortical, bone mass and microstructure and to obtain preliminary data to inform the design of a future randomized study. This study presents the first opportunity to study the effects of denosumab after TPTD in this unique and severely affected group of young women.
Funding Source: FDA Office of Orphan Products Development (OOPD).
Osteoporosis in premenopausal women with normal menstrual function and no specific cause is termed idiopathic osteoporosis (IOP). IOP is a rare disease with an estimated prevalence of <200,000 affected premenopausal women in the United States.
Denosumab, a potent inhibitor of osteoclast-mediated bone resorption, leads to continuous gains in both trabecular and cortical bone mineral density (BMD). Moreover, denosumab is not retained in the skeleton, and may thus be preferable for use in young women who may be contemplating future pregnancies. The investigators hypothesize that denosumab, initiated after completion of two years of TPTD, will maintain or improve central and peripheral areal and volumetric BMD, microstructure and stiffness in premenopausal women with IOP.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Denosumab | Experimental | Denosumab 60mg, administered every 6 months by subcutaneous injection for 36 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Denosumab | Drug | Denosumab 60mg, administered every 6 months by subcutaneous injection for 36 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Lumbar Spine Areal BMD by DXA | Bone mineral density (BMD) will be measured with dual-energy X-ray absorptiometry (DXA). | Baseline and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Lumbar Spine Areal BMD by DXA at 24 Months | Bone mineral density (BMD) will be measured with dual-energy X-ray absorptiometry (DXA). | Baseline and 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Shane, MD | Columbia University | Principal Investigator |
| Adi Cohen, MD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Creighton University | Omaha | Nebraska | 68131 | United States | ||
| Columbia University Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34849989 | Derived | Shane E, Shiau S, Recker RR, Lappe JM, Agarwal S, Kamanda-Kosseh M, Bucovsky M, Stubby J, Cohen A. Denosumab After Teriparatide in Premenopausal Women With Idiopathic Osteoporosis. J Clin Endocrinol Metab. 2022 Mar 24;107(4):e1528-e1540. doi: 10.1210/clinem/dgab850. |
| Label | URL |
|---|---|
| Columbia University, Dept of Medicine, Division of Endocrinology website | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Denosumab | Denosumab 60mg, administered every 6 months by subcutaneous injection for 36 months. Denosumab: Denosumab 60mg, administered every 6 months by subcutaneous injection for 36 months |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Denosumab | Denosumab 60mg, administered every 6 months by subcutaneous injection for 36 months. Denosumab: Denosumab 60mg, administered every 6 months by subcutaneous injection for 36 months |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Change in Lumbar Spine Areal BMD by DXA | Bone mineral density (BMD) will be measured with dual-energy X-ray absorptiometry (DXA). | 33 participants completed baseline but 1 participant withdrew from the study before the 12 month visit. | Posted | Mean | Standard Deviation | percentage of change | Baseline and 12 months |
|
|
Adverse event data was collected for 1 year (from baseline to 12 month study participation).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Denosumab | Denosumab 60mg, administered every 6 months by subcutaneous injection for 36 months. Denosumab: Denosumab 60mg, administered every 6 months by subcutaneous injection for 36 months |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment | Nonvertebral fragility fracture |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mariana Bucovsky | Columbia University | 212-305-7225 | mb3523@cumc.columbia.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 17, 2017 | Mar 25, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069448 | Denosumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| New York |
| New York |
| 10032 |
| United States |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Secondary | Percent Change in Lumbar Spine Areal BMD by DXA at 24 Months | Bone mineral density (BMD) will be measured with dual-energy X-ray absorptiometry (DXA). | Posted | Mean | Standard Deviation | percentage of change | Baseline and 24 months |
|
|
|
| 0 |
| 33 |
| 0 |
| 33 |
| 26 |
| 33 |
|
| Redness | Surgical and medical procedures | Systematic Assessment | Redness at injection site reaction |
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| Pain | Surgical and medical procedures | Systematic Assessment | Injection site reaction |
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| Urinary tract infection | Infections and infestations | Systematic Assessment |
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| Ear infection | Infections and infestations | Systematic Assessment |
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| Eczema | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Hair loss | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Muscle cramps | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Numbness and/or tingling | Nervous system disorders | Systematic Assessment |
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| Nausea and vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Pain in thighs, hips, or groin | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Cold | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Joint pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Low Energy | General disorders | Systematic Assessment |
|
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| D009750 |
| Nutritional and Metabolic Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |